Amgen Senior C&Q Engineer Jobs – USA

Amgen Seeks Engineering Lead for Cutting-Edge Manufacturing Facility, Driving Innovation in Biotech

Amgen, a global biotechnology leader, is actively recruiting a Senior Engineer to spearhead Commissioning and Qualification (C&Q) efforts at its newest, state-of-the-art drug substance manufacturing plant. This strategic hire underscores Amgen’s commitment to accelerating the delivery of innovative medicines to patients battling serious illnesses.

Pioneering Biotech Since 1980

Since its founding in 1980, Amgen has been at the forefront of biotechnology, dedicated to addressing some of the world’s most challenging diseases. The company focuses its research and development on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, impacting millions of patients annually. “If you feel like you’re part of something bigger at Amgen, it’s because you are,” a company release stated, emphasizing the collaborative and mission-driven culture.

The FleX Batch Facility: A Leap Forward in Manufacturing

The upcoming Amgen FleX batch facility represents a significant investment in advanced manufacturing capabilities. Designed for maximum operational flexibility, the plant will integrate both single-use technologies and traditional stainless steel equipment. Beyond its technological advancements, the facility will prioritize sustainability, aligning with Amgen’s ambitious goal to become carbon-neutral by 2027. The facility will also feature Industry 4.0 capabilities.

Role Overview: Commissioning & Qualification Engineering Lead

The C&Q Engineering Lead will provide strategic direction, technical oversight, and operational management for the Equipment & Warehouse (EW) C&Q function. This role is critical in ensuring compliance, efficiency, and consistency in validation practices across all capital projects, site initiatives, and ongoing system lifecycle activities. The position demands strong technical expertise, cross-functional collaboration, and the ability to drive improvements at both local and network levels.

Key responsibilities include:

• Serving as the Commissioning & Qualification Lead (CQL) for departmental capital projects, overseeing documentation, CCMS assessments, and project alignment.
• Collaborating with project leads to define project scope, estimate C&Q effort, and allocate engineering resources.
• Managing the entire lifecycle of the validation maintenance program, from annual scope development to cost negotiation and progress tracking.
• Ensuring inspection readiness through playbook maintenance, IRF responses, and presentations to auditors.
• Supporting construction and capital project teams with C&Q oversight.
• Leading efficiency improvements through the development of automation and AI tools for periodic reviews and audit trail assessments.
• Participating in global C&Q, validation, computerized systems, and data integrity networks, sharing insights with site teams.
• Managing C&Q-related deviations as assigned.

Ideal Candidate Profile

Amgen seeks a project management professional who embodies the company’s values and possesses the following qualifications:

Basic Qualifications:

• High school diploma/GED with 12 years of Commissioning, Qualification, and Validation (C&Q) experience.
• Associate’s degree with 10 years of C&Q experience.
• Bachelor’s degree with 6 years of C&Q experience.
• Master’s degree with 4 years of C&Q experience.
• Doctorate degree with 4 years of C&Q experience.

Preferred Qualifications:

• Demonstrated leadership experience in managing technical teams or leading complex, cross-functional initiatives.
• A strong understanding of Good Manufacturing Practice (GMP) regulations, validation lifecycle requirements, data integrity principles, and C&Q best practices.
• Experience serving as a CQL or validation lead on capital projects.
• Proven ability to interface with auditors and respond to regulatory inspection requests.
• Familiarity with automated systems, CCMS/CMMS platforms, and AI/automation tools for compliance workflows.
• Excellent communication, stakeholder engagement, and decision-making skills.
• The ability to manage competing priorities in a dynamic environment and influence without direct authority.
• Strong analytical skills and the ability to translate technical data into actionable insights.
• Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry is highly desirable.

Amgen’s Commitment to Growth and Well-being

Amgen is dedicated to fostering a collaborative culture that supports both professional and personal growth. The company offers competitive benefits and comprehensive Total Rewards Plans aligned with industry standards. “We’ll support your journey every step of the way,” according to a company statement.

Interested candidates are encouraged to apply online at careers.amgen.com.

Amgen is an Equal Opportunity employer committed to diversity, inclusion, and ethical conduct, striving to advance science and serve patients worldwide. The company actively encourages applications from individuals with diverse backgrounds and experiences. Reasonable accommodations are available for individuals with disabilities throughout the job application and employment process.